Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes (Jom Mama)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Other: standard antenatal care; Behavioral: lifestyle intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617693

U1111-1160-2987 (Other Identifier)

INS-4186

Details and patient eligibility

About

This study is conducted in Asia. The aim of this study is to assess the efficacy of a pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.

Enrollment: 552 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Nulliparity
• Not pregnant at the time of signing informed consent
• Own a smartphone with either Android system version 4.1 and above or iOS system 7.0 and above with internet access

Exclusion criteria

• Female subject undergoing treatment for type 1 or 2 diabetes mellitus
• Subjects not residing in the district of Seremban

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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552 participants in 2 patient groups

Standard of care

Other group

Treatment:

Other: standard antenatal care

Life style intervention

Experimental group

Treatment:

Behavioral: lifestyle intervention